Myrbetriq® Patent Invalidated On Grounds Not Asserted by Any Party Violating Party Presentation Principle

Attorney: Richard D. Kelly
October 2, 2024

In Astellas Pharma Inc. v. Sandoz Inc,, et al, following a five-day patent claims bench trial the court found asserted claims 5, 20, and 25 invalid under 35 U.S.C. § 101 even though Sandoz had not asserted 101 as defense at any time during the case.  The parties had agreed to limit the issue to claims 5, 20, and 25 and the defense to invalidity under 35 U.S.C. § 112.  Neither party had notice that patent eligibility was an issue.  In making his ruling Judge Bataillon relied upon a statement in Astellas post-trial brief that the “inventive concept of the ’780 Patent was discovering the dissolution rate that would address the food effect and achieving it using previously known formulation technology.”  Thus, because the claimed invention “reflects merely the discovery of the food-effect-resolving dissolution profile,” the district court deemed the asserted claims invalid as patent ineligible.  Not only had the issue of patent eligibility not been raised by the defendant, but the claims were also to a specific composition.  Recognizing the district court had gone on astray Sandoz moved the court to make additional findings of fact  advising the court that the § 101 defense had not been raised as a defense and that the decision must be based on the language in the claims.  The motion was denied.<... Read more

USPTO Seeks Public Feedback on The Experimental Use Exception to Patent Infringement

Attorney: Evan Smith
July 26, 2024

On June 27, 2024, the United States Patent and Trade Office (“USPTO”) published a request for comments (“RFC”) in the Federal Register inquiring about the current state of the experimental use defense to patent infringement and to determine the potential value of legislative action on the issue.  This RFC both supports the President’s 2021 Executive Order on Promoting Competition in the American Economy and furthers the United States Department of Agriculture and the USPTO’s joint commitment to evaluate “New proposals for incentivizing and protecting innovation in the seed and agricultural-related space, including the addition of research or breeders' exemptions for U.S. utility patents.”[1]<... Read more

PTAB Reverses Examiners on Unexpected Results

Attorney: Derek Lightner, Ph.D.
June 11, 2024

In Ex parte Freeman (USSN 16/270,259; TC 1600; Appeal 2023-000512, the underlying application being referred to herein as the “Freeman application”), a finding of obviousness and obviousness-type double patenting (ODP) was reversed on May 24, 2024. Freeman’s application was examined by Devang Thakor initially, but the case was taken over by another primary examiner, Nicole Babson, whose position was supported by Supervisor Patent Examiners, David Blanchard and Bethany Barham.<... Read more

When does a drug label induce infringement under 35 U.S.C. § 271(e)(2) of a patent not claiming an indication or method of use?

Attorney: Richard D. Kelly
January 23, 2024

In Corcept Therapeutics, Inc. v. Teva Pharmaceuticals U.S.A., Inc., C.A. 18-03632, December 29, 2023, the Chief Judge Bumb of the New Jersey District Court wrestled with the question of infringement under 35 U.S.C. 271(e)(2) where the drug labels of the generic and ethical drug were identical in the relevant parts.<... Read more

Federal Circuit Reiterates What Constitutes A Motivation to Combine, A Reasonable Expectation of Success, and Unexpected Results in New Chemical Compounds

Attorney: Sara Pistilli, PharmD.
August 30, 2023

In Sun Pharmaceutical Industries, Inc. v. Incyte Corporation, on August 22, 2023, the Federal Circuit affirmed a Final Written Decision of the Patent and Trial Appeal Board (the Board) of an inter partes review (IPR) asserting the claims of U.S. Patent No. 9,249,149 (the ’149 patent) as obvious under 35 U.S.C. § 103. The central argument was whether Sun’s “octo-deuterated” ruxolitinib analog (CTP-543) and “tetra-deuterated” ruxolitinib analogs, arising from claim 7 of the ’149 patent, were obvious in light of the prior art references presented by Incyte (Rodgers, Shilling, and the Concert Backgrounder).

Claim 7 recited:

The compound of claim 1, in which the compound is selected from the group consisting of:




or a pharmaceutically acceptable salt of any of the foregoing.<... Read more